NCT02710760

Brief Summary

The purposes of this study are (1) to determine whether child nutrition-focused adoption encouragement messages focused on Quality Protein Maize (QPM) and the availability of small quantities of QPM seed can be effective at increasing QPM adoption and health outcomes for young children, and (2) to determine whether consumption encouragement messages and techniques (e.g., containers for earmarking) can be effective at increasing QPM targeting to and health outcomes for young children.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
978

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 29, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 17, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

March 9, 2017

Status Verified

March 1, 2017

Enrollment Period

1 year

First QC Date

February 29, 2016

Last Update Submit

March 8, 2017

Conditions

Keywords

BiomarkersChild Nutrition SciencesEconomics, Behavioral

Outcome Measures

Primary Outcomes (33)

  • Consumption of any QPM by the index child in the last 24 hours

    6-7 months

  • Amount of QPM consumed by the index child in the last 24 hours

    6-7 months

  • Index child's proportion of total maize consumption that was QPM in the last 24 hours

    6-7 months

  • Consumption of any QPM by the index child in the last week

    6-7 months

  • Number of days in the last week that the index child ate any QPM

    6-7 months

  • Number of days in the last week that caregiver cooked a QPM-based food that was primarily for target children

    6-7 months

  • Height-for-age Z-score of index child

    6-7 months

  • Weight-for-height Z-score of index child

    6-7 months

  • Weight-for-age Z-score of index child

    6-7 months

  • Mid-upper arm circumference-for-age Z-score of index child

    6-7 months

  • Insulin-like growth factor I (continuous measurement)

    6-7 months

  • Amount of QPM reserved for home consumption

    6-7 months

  • Hectares of QPM planted

    6-7 months

  • Serum transthyretin

    6-7 months

  • Consumption of any QPM by the index child in the last 24 hours

    10-11 months

  • Amount of QPM consumed by the index child in the last 24 hours

    10-11 months

  • Index child's proportion of total maize consumption that was QPM in the last 24 hours

    10-11 months

  • Consumption of any QPM by the index child in the last week

    10-11 months

  • Number of days in the last week that the index child ate any QPM

    10-11 months

  • Number of days in the last week that caregiver cooked a QPM-based food that was primarily for target children

    10-11 months

  • Height-for-age Z-score of index child

    10-11 months

  • Weight-for-height Z-score of index child

    10-11 months

  • Weight-for-age Z-score of index child

    10-11 months

  • Mid-upper arm circumference-for-age Z-score of index child

    10-11 months

  • Amount of QPM reserved for home consumption

    10-11 months

  • Change in Height-for-age Z-score of index child

    6-7 months

  • Change in Height-for-age Z-score of index child

    10-11 months

  • Change in Weight-for-height Z-score of index child

    6-7 months

  • Change in Weight-for-height Z-score of index child

    10-11 months

  • Change in Mid-upper arm circumference-for-age Z-score of index child

    6-7 months

  • Change in Mid-upper arm circumference-for-age Z-score of index child

    10-11 months

  • Change in Weight-for-age Z-score of index child

    6-7 months

  • Change in Weight-for-age Z-score of index child

    10-11 months

Secondary Outcomes (2)

  • Serum lysine

    6-7 months

  • Serum tryptophan

    6-7 months

Study Arms (3)

Control

NO INTERVENTION

Households in the control group receive no special treatment.

Adoption Encouragement Treatment

EXPERIMENTAL

Households in the Adoption Encouragement Treatment group were visited between March and April 2015 and offered "child nutrition focused" adoption encouragement. Both the male household head and the primary female caregiver were invited to attend these meetings (though the household head is the primary target), where the nutritional benefits of Quality Protein Maize (QPM) adoption for children were emphasized along with the agronomic properties. In addition, the fact that only small amounts of QPM are necessary to nourish children was highlighted and small seed bag sizes were offered. During the adoption encouragement visit, we offered the option to order up to three 2 kg bags of QPM for free.

Other: Adoption Encouragement Treatment

Consumption Encouragement Treatment

EXPERIMENTAL

In addition to receiving the Adoption Encouragement Treatment, households in the Consumption Encouragement Treatment group received additional information, targeted to the caregiver, and tools for separating Quality Protein Maize and targeting it to young children in the household in August 2015. They will additionally receive further guidance in February 2016.

Other: Adoption Encouragement TreatmentOther: Consumption Encouragement Treatment

Interventions

Households in the Adoption Encouragement Treatment received child nutrition focused guidance on the nutritional and agronomic benefits of Quality Protein Maize (QPM) adoption, and the opportunity to order up to 6 kg of QPM seed to plant in their own fields.

Adoption Encouragement TreatmentConsumption Encouragement Treatment

Households in the Consumption Encouragement Treatment received the same guidance as households in the Adoption Encouragement Treatment, as well as additional guidance on the importance of specifically targeting foods made with QPM to young children and tools to help households keep the grain separate and remember to feed QPM-based foods to the young children.

Consumption Encouragement Treatment

Eligibility Criteria

Age6 Months - 35 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may not qualify if:

  • Households in the study areas that do not have a member who attends a field day demonstrating Quality Protein Maize or who do not have a child in the appropriate age range are excluded from the study. Furthermore, households where the mother or children did not intend on staying in the region for the study duration (until the completion of the endline survey) were excluded from the study. Finally, we excluded participants who do not have access to land for crop cultivation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (7)

  • Black RE, Victora CG, Walker SP, Bhutta ZA, Christian P, de Onis M, Ezzati M, Grantham-McGregor S, Katz J, Martorell R, Uauy R; Maternal and Child Nutrition Study Group. Maternal and child undernutrition and overweight in low-income and middle-income countries. Lancet. 2013 Aug 3;382(9890):427-451. doi: 10.1016/S0140-6736(13)60937-X. Epub 2013 Jun 6.

    PMID: 23746772BACKGROUND
  • Victora CG, Adair L, Fall C, Hallal PC, Martorell R, Richter L, Sachdev HS; Maternal and Child Undernutrition Study Group. Maternal and child undernutrition: consequences for adult health and human capital. Lancet. 2008 Jan 26;371(9609):340-57. doi: 10.1016/S0140-6736(07)61692-4.

    PMID: 18206223BACKGROUND
  • Ruel MT, Alderman H; Maternal and Child Nutrition Study Group. Nutrition-sensitive interventions and programmes: how can they help to accelerate progress in improving maternal and child nutrition? Lancet. 2013 Aug 10;382(9891):536-51. doi: 10.1016/S0140-6736(13)60843-0. Epub 2013 Jun 6.

    PMID: 23746780BACKGROUND
  • Masset E, Haddad L, Cornelius A, Isaza-Castro J. Effectiveness of agricultural interventions that aim to improve nutritional status of children: systematic review. BMJ. 2012 Jan 17;344:d8222. doi: 10.1136/bmj.d8222.

    PMID: 22251864BACKGROUND
  • Girard AW, Self JL, McAuliffe C, Olude O. The effects of household food production strategies on the health and nutrition outcomes of women and young children: a systematic review. Paediatr Perinat Epidemiol. 2012 Jul;26 Suppl 1:205-22. doi: 10.1111/j.1365-3016.2012.01282.x.

    PMID: 22742612BACKGROUND
  • Ghosh S, Suri D, Uauy R. Assessment of protein adequacy in developing countries: quality matters. Br J Nutr. 2012 Aug;108 Suppl 2:S77-87. doi: 10.1017/S0007114512002577.

    PMID: 23107551BACKGROUND
  • Donato K, McConnell M, Han D, Gunaratna NS, Tessema M, De Groote H, Cohen J. Behavioural insights to support increased consumption of quality protein maize by young children: a cluster randomised trial in Ethiopia. BMJ Glob Health. 2020 Dec;5(12):e002705. doi: 10.1136/bmjgh-2020-002705.

MeSH Terms

Conditions

MalnutritionBehavior

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • Jessica Cohen, PhD

    Harvard Chan School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Global Health

Study Record Dates

First Submitted

February 29, 2016

First Posted

March 17, 2016

Study Start

July 1, 2015

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

March 9, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will share

We will share completely deidentified data upon request after primary analyses have been been completed.